RWD SIG

Purpose

To increase collaboration and enhance awareness of strategies and methodologies applied in the utilization of Real World Data in the pharmaceutical industry.

Objectives

Our objectives include:

  • Facilitate sharing of case studies and experiences in this area
  • Collate and summarise publications, articles, presentations, training
  • Identify emerging news and trends
  • Organise and/or participate in workshops related to RWD
  • Collaborate with key stakeholder groups (EFSPI/PSI, EFPIA, ISPOR,  regulatory and academia)
  • Provide comments on RWD related guidelines, e.g. country-specific methods guidelines, FDA methods guidelines, ISPOR etc.
  • Develop/highlight best practices and recommendations
  • Influence industry practice and acceptance of approaches by regulators and other stakeholders

 

Let's T@lk Real Corner

This corner is created to discuss Real World Data (RWD) topics coming from industry, academia and Health Authorities.

Blog Posts:

Let's T@lk Real: Federated Data 9th December 2024

Let's T@lk Real: Immortal Time Bias and Time Zero 22 April 2024

Let's T@lk Real: DAGs 5th December 2023

Let's T@lk Real: What are RWD 3rd July 2023

Let's T@lk Real: External Controls 22nd May 2023

Let's T@lk Real: Survey 19th December 2022

 

Who we are

SIG MemberOrganisation
Antonio Remiro-AzocarNovo Nordisk
Deepak ParasharWarwick University
Eleanor RalphsIQVIA
Elizabeth MerrallJanssen
Fiona GrimsonUCB
Federica BelmonteNovo Nordisk
Helen BroadhurstPlus-Project
Jixian (Jason) WangBristol Myers Squibb
Josie Wolfram (Co-chair)Astellas
Laura DayAdaptimmune
Louise LinsellVisible Analytics Limited
Min-Hua JenEli Lilly
Orlando DoehringGSK
Rachel ThamAstellas
Rima Izem (Co-chair)Novartis
Thomas DebraySmart Data Analysis and Statistics B.V.
Victoria StraussBoehringer Ingelheim

 

We also have an observer/informed member list who are included on meeting invites and mails, but we don’t expect active contributions nor list you on the SIG page members list. Shifting status to active is then welcomed any time!

Call for members

If you are interesting in joining the RWD SIG or would like to change your PSI RWD SIG membership status, please use the sign up form.

Frequency of Meetings

Monthly teleconferences

 

Upcoming Events

PSI Introduction to Industry Training (ITIT) Course - 2025/2026

An introductory course giving an overview of the pharmaceutical industry and the drug development process as a whole, aimed at those with 1-3 years' experience. It comprises of six 2-day sessions covering a range of topics including Research and Development, Toxicology, Data Management and the Role of a CRO, Clinical Trials, Reimbursement, and Marketing.

Joint PSI/EFSPI Visualisation SIG 'Wonderful Wednesday' Webinars

Our monthly webinar explores examples of innovative data visualisations relevant to our day to day work. Each month a new dataset is provided from a clinical trial or other relevant example, and participants are invited to submit a graphic that communicates interesting and relevant characteristics of the data.

PSI Webinar: Applying the Estimand Framework to Clinical Pharmacology Trials with a Case Study in Bioequivalance

This will be a 45 minute webinar which will explain the topic presented in the published paper, ‘Applying the Estimand Framework to Clinical Pharmacology Trials with a Case Study in Bioequivalance’. There will be 15 minutes for a panel Q&A with some of the authors following the presentation.

PSI Webinar: Methodology and first results of the iRISE (improving Reproducibility In SciencE) consortium

This 1-hour webinar will be an opportunity to hear about the methodology and first results of the iRISE consortium. iRISE is working towards a better understanding of reproducibility and the interventions that work to improve it. At the end of the presentation there will also be the opportunity to ask questions.

One-day Event: Change Management for Moving to R/Open-Source

This one-day event focuses on the comprehensive management of transitioning to R/Open-Source, addressing the challenges and providing actionable insights. Attendees will participate in sessions covering essential topics such as training best practices, creating strategic plans, making the case to senior management, and managing both statistical and programming aspects of the transition.

Latest Jobs

Principal Statistician - Labcorp

This is an exciting, new opportunity for an experienced Statistician looking to take the next step in their career. Offered as a remote or hybrid position aligned with our site in Harrogate, North Yorkshire.